Application 020098

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIVACRON	MIVACURIUM CHLORIDE	SOLUTION;INTRAVENOUS	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	MIVACURIUM CHLORIDE	INJECTABLE;INJECTION	EQ 0.5MG BASE/ML	No	No
003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	MIVACURIUM CHLORIDE	INJECTABLE;INJECTION	EQ 50MG BASE/100ML	No	No
004	MIVACRON	MIVACURIUM CHLORIDE	SOLUTION;INTRAVENOUS	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	Yes	No
005	MIVACRON	MIVACURIUM CHLORIDE	SOLUTION;INTRAVENOUS	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020098-001	MIVACRON	MIVACURIUM CHLORIDE	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22
N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	MIVACURIUM CHLORIDE	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22
N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	MIVACURIUM CHLORIDE	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22
N020098-004	MIVACRON	MIVACURIUM CHLORIDE	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22
N020098-005	MIVACRON	MIVACURIUM CHLORIDE	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-05-31 18:47 UTC	2024-05	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020098-001	MIVACRON	EQ 2MG BASE/ML (EQ 2MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020098-002	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION		1992-01-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020098-003	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION		1992-01-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020098-004	MIVACRON	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020098-005	MIVACRON	EQ 20MG BASE/10ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	1992-01-22	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55044	SUPPL	2018-07-30
55026	SUPPL	2018-07-27
12210	SUPPL	2015-02-03
2016	SUPPL	2010-11-30
34260	SUPPL	2010-11-22
34259	SUPPL	2004-06-09
21148	SUPPL	2004-06-09
2015	SUPPL	2002-06-04
41143	SUPPL	2000-07-03